On May 31, 2021, TOT BIOPHARM (Stock code:1875.HK) announced that its self-developed Temozolomide Capsules (TOZ309) obtained marketing approval from the National Medical Products Administration (NMPA) for the treatment of (1) newly diagnosed glioblastoma multiforme, initially combined with radiotherapy, and then as maintenance therapy; and (2) glioblastoma multiforme or anaplastic astrocytoma that recurs or progresses after conventional treatment.

Temozolomide capsules (TOZ309) was field for marketing as an NMPA New category 4 chemical drug (generic drug), the specifications of which include 20mg x 5 capsules/bottle and 100mg x 5 capsules/bottle under the proposed trademark Tazian^®. The results of the clinical study showed that TOT BIOPHARM’s Timozolomide capsules 20mg/capsule and 100mg/capsule were bioequivalent to TEMODAR^® 20mg/capsule and 100mg/capsule, respectively, and were similar to TEMODAR^®, and no unintended serious adverse events related to the study drug occurred during the study period.

A large Phase-III clinical trial by the European Organization for Research and Treatment of Cancer and the National Cancer Institute of Canada demonstrated that temozolomide (TMZ) combined with concurrent radiotherapy followed by 6 cycles of TMZ adjuvant chemotherapy prolonged survival in patients with glioblastoma multiforme (GBM), increasing the 2-year survival rate from 10.4% to 26.5%. After surgery, Temozolomide concurrent radiotherapy combined with adjuvant chemotherapy has become the standard of care for newly diagnosed glioblastoma.

In China, only three types of Temozolomide capsules, including the original drug, are available on the market. The original drug, TEMODAR^®, was approved by the Federal Drug Administration (FDA) in 1999 and entered the Chinese market in 2007. According to Frost & Sullivan, the market for Temozolomide capsules in China reached 1.8 billion yuan in 2018, and is expected to increase to 2.5 billion yuan by 2023.

Dr. Jun Liu, CEO of TOT BIOPHARM, commented,

We are excited about the successful launch of TOZ309 Tazian^® (Temozolomide Capsules), which means that TOT BIOPHARM's self-developed drugs have entered a harvest period. We will continue to enrich our product pipeline, accelerate the drug development and commercialization process, and provide patients with even better treatment regimens.

About Temozolomide Capsules (proposed trademark: Tazian^®)

Temozolomide capsules are the generic product of TEMODAR^® (Temozolomide capsules), an alkylating agent of the imidazotetrazine class with antitumor activity that kills cancer cells by damaging DNA. With enhanced efficacy and reduced side effects compared to conventional chemotherapy, Temozolomide capsules are used as a first-line drug for newly diagnosed and recurrent gliomas.